Team Lead - CMC Systems Oversight
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
Team Lead - CMC Systems OversightApply Now
Job Description – Associate Director, Systems Oversight
- Demonstrates a high level of leadership and understanding of GRA-CMC roles, capabilities, and applicable CMC and GXP requirements relevant to the development and maintenance of systems and processes related to
- Change management
- Regulatory submissions
- Post-marketing commitments
- Clinical and commercial supply
- Represents GRA-CMC on cross-functional teams developing and maintaining Quality, Supply and regulatory systems
- Manages, develops and mentors staff members responsible for GRA-CMC change management procedures
- Proactively recognizes and contributes to enhancing business processes
- Responsible for adapting, developing or maintaining GRA-CMC procedures in accordance with Global, GRA, and PharmSci and GMS/GQ policies and standards
- Responsible for developing and communicating meaningful metrics for post-approval submissions to facilitate resourcing decisions and planning
- Responsible for supporting post-approval submissions and projects as an individual contributor where needed
- Exercises good judgement in elevating and communicating actual or potential issues to line management
- Ensures that stakeholders are kept aware of developments around systems and processes that have the potential to impact GRA-CMC resources and priorities
Education, Behavioral Competencies and Skills
- Demonstrates Takeda’s leadership behaviors
- Understanding of change control, regulatory submission requirements
- Flexible, pragmatic, good communicator
- Demonstrates ability to think strategically on systems issues, anticipate potential roadblocks and to collaborate with stakeholders to solve problems
- Experience leading a team preferred
Job ID R0015571